“Tomatoes May Be Dangerous to Your Health” was the headline of an opinion piece published on June 1, 1992 by the New York Times. In it, Sheldon Krimsky criticized the exemption of genetically engineered crops from certain levels of review by the Food and Drug Administration (“FDA”). He was referring to the Flavr Savr’ Tomato, the first genetically engineered food later to be granted a license for human consumption by the FDA. That species of tomato included engineered genes that were to slow the natural softening process that accompanies ripening. The idea was that the tomatoes could spend more time on the vine than other tomato species, producing more flavor, but still remaining firm enough to ship.

In response to Krimsky’s article, Paul Lewis wrote a Letter to the Editor in which he coined the term Frankenfood to refer to food derived from genetically engineered crops:

Ever since Mary Shelley’s baron rolled his improved human out of the lab, scientists have been bringing just such good things to life. If they want to sell us Frankenfood, perhaps it’s time to gather the villagers, light some torches and head to the castle.

The term caught on and many still continue to use it in referring to food produced from genetically engineered crops.

The reality is that humanity has been engaging in a form of genetic manipulation of crops even since the earliest days of agriculture, but such processes were a result of selective breeding rather than through direct manipulation of genes. Consider the case of milk production, for example. As a result of identifying bulls who have highly desirable genes, the number of bulls that are used to sire dairy cows is astonishingly small, resulting in a very narrow range of genetic diversity among cattle in the dairy industry. At the time of his death in 1997, for example, the Dutch Holstein Friesian bull named Sunny Boy had sired some two million calves. The impact on the genetic origin of dairy products throughout the world was a direct result of human intervention in natural processes. Or consider the production of soybeans. In the 1990’s, the entire soybean crop in the United States — some 60 million tons — was descended from a mere dozen soybean strains that had been collected in northeastern China.

Since the FDA approved human consumption of the Flavr Savr’ Tomato in 1994, there has been a huge infiltration of genetically modified crops into the food supply, especially in the United States where more than 90% of the soybean, cotton, and canola markets are supplied by genetically modified crops. Byproducts of those crops — notably soy lecithin — are found in thousands of processed-food products: chocolate bars, baby foods, margarine, breakfast cereals, and many others.

This week, the FDA is conducting hearings as part of its consideration whether to allow human consumption of AquAdvantage, a genetically modified species of Atlantic salmon that some are — inevitably — calling a frankenfish. The application was submitted to the FDA in 1995, but the agency has so far never approved any genetically modified animal for human consumption. AquAdvantage has been modified so that it grows twice as fast as its natural counterpart. Critics have expressed two concerns: that the effect on people who consume the fish is unknown and that if the genetically engineered fish escapes, it may have a negative impact on the natural salmon population. These concerns are not frivolous ones: salmon populations are already depleted because of overfishing, and if the genetically modified fish grows at twice the speed as naturally occurring salmon, there is a possibility of disrupting the food supply for natural salmon populations.

It can be difficult to predict all of the effects of genetic modification of organisms. For example, there is a known history of genetically modified plants producing substances they hadn’t produced before or of repressing the production of substances they normally produce: transgenic potatoes that were supposed to make more starch and less sugar did the opposite; transgenic tomatoes that were made to produce excess carotene became unexpectedly smaller; and perhaps most notably, reproduction mechanisms of some plants changed so that inserted genes unexpectedly started appearing in other plant species.

Surveys confirm that there is generally a strong desire by people in the United States to have food labeled as arising from genetically modified organisms, something that the FDA has never required. Industry interests in the United States generally oppose labeling — jurisdictions elsewhere in the world where labeling is required, notably the European Union and Japan, find almost no one willing to buy food derived from genetically modified organisms.

The FDA has taken the position, however, that federal law, when properly construed, actually prohibits the agency from requiring labeling of food derived from genetically modified plants. The relevant law that the FDA cites is found in the Food, Drug, and Cosmetic Act (21 U.S.C. §343) and prohibits a variety of food labeling that is “false” or “misleading.” The FDA has concluded that because it has generally found food derived from genetically modified sources not to be “materially different” than food derived from natural sources, it cannot require labeling, and this position has been upheld in court: Alliance for Bio-Integrity v. Shalala, 116 F.Supp.2d 166 (D.D.C. 2000). Producers of genetically modified food are permitted to add labels if they wish, but none do.

It seems likely that AquAdvantage will be approved for human consumption in due course. One of the objectives of the hearings is to determine whether the FDA’s position on labeling should be different because this is an animal to be consumed rather than a plant. Some background material on the labeling issue prepared by the FDA can be read here.

It was only three years after the release of the Flavr Savr’ Tomato that its producer Calgene needed to withdraw it from the market. They were sold under the brand name MacGregor’s in California and a few places in the Midwest of the United States. But they turned out to be more delicate than expected, bruising easily so that special trucks were needed for transportation. Delivery of the tomatoes to grocery stores became prohibitively expensive. Perhaps AquAdvantage will be no more successful in the end. But whether it is approved soon by the FDA or not, it is clear that consumption of such animals is a genie that will soon be out of the bottle and very unwilling to get back in.